Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Regulatory Affairs

To improve ANDA submissions, the FDA should spend more time with generics companies before they file an application, as is done with brand manufacturers in the run-up to an NDA, the Generic Pharmaceutical Association says. Read More

The FDA is mulling changes to the way it determines eligibility for 180-day generic exclusivity, including opening up the exclusivity decision-making process to the public, and it’s inviting industry to offer feedback on the idea. Read More

The FDA’s newly created four-point sliding scale of comparability between original biologic products and their biosimilars does not belong in guidance on data to demonstrate that similarity, PhRMA says. Read More

Indian generics makers have hired a U.S.-based lobbyist to head off the threat of a trade downgrade and polish an image that has been tarnished by FDA import bans and warning letters for manufacturing practice violations. Read More

Regulators in Australia are seeking input on proposed changes to drug labelling regulations that could save the public health system up to $30 million annually in hospital admission costs attributed to medication errors, but would cost industry millions of dollars to implement. Read More

Brazil's Anvisa issued a rule on June 18 establishing criteria for the priority review of small molecule drugs and biologics. Rule No. 37 applies to marketing authorization, postauthorization and clinical study applications. Read More

Australian regulators are seeking industry input on the pilot phase of a new system that will let drugmakers submit applications electronically, as the country prepares to fully adopt the software next year. Read More

The FDA is explaining how generics firms can receive timely responses to their requests for information in a guidance that defines a new communications process known as “controlled correspondence.” Read More

The FDA is mulling changes to the way it determines eligibility for 180-day generic exclusivity, including opening up the exclusivity decision-making process to the public, and it’s inviting industry to offer feedback on the idea. Read More

Roche got the greenlight on Thursday to market its blockbuster cancer drug Avastin for the treatment of advanced cervical cancer, making it the first biologic drug approved in combination with chemotherapy for the disease. Read More